(134 days)
Single-Use Digital Flexible Ureteroscope (F-URS)(ZSR-URS-02, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) : This product is used in medical institutions, in conjunction with our electronic endoscope image processor. for imaging in examination, diagnosis or treatment of urinary system diseases.
Endoscope Imaging Processor (ZSR-EOS10) : Applicable to medical institutions, which are connected with electronic endoscopic diagnosis and/or treatment/surgery, and effectively display images of the field of view areas of human body cavities observed by endoscopes on monitors.
Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) Single-Use Digital Flexible Ureteroscope (F-URS) is used in medical institutions, in conjunction with our electronic endoscope image processor, for imaging in examination, diagnosis or treatment of urinary system diseases. This device uses ethylene oxide (EO) sterilization process. This product consists of two main parts: an operating handle with directional control and connecting wires, as well as a flexible insertion tube.
Electronic Endoscope Imaging Processor (ZSR-EOS10) Applicable to medical institutions, which are connected with electronic endoscopes during endoscopic diagnosis and/or treatment/surgery, and effectively display images of the field of view areas of human body cavities observed by endoscopes on monitors. The device is composed of aluminum alloy chassis and motherboard and power supply components.
The Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) and Electronic Endoscope Imaging Processor make up the video ureteroscope system.
The provided text is for a 510(k) premarket notification for a Single-Use Digital Flexible Ureteroscope (F-URS) and an Electronic Endoscope Imaging Processor. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness through extensive clinical trials. Therefore, the information regarding acceptance criteria and performance studies will differ significantly from what would be found in a submission for a new AI/software device that requires proving clinical benefit.
Based on the provided text, here's an analysis of the acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance for this device is based on substantial equivalence to existing predicate devices, not on specific performance metrics established as acceptance criteria for clinical efficacy. The "acceptance criteria" here refer to meeting recognized standards for medical devices of this type, ensuring safety, and demonstrating that any differences from the predicate do not raise new questions of safety or effectiveness.
| Performance Characteristic | Acceptance Criteria (Standard Reference) | Reported Device Performance (Compliance) | Notes from Document |
|---|---|---|---|
| Performance Testing | ISO 16926-6:2014 | Conforms | Endoscope Image Quality |
| ISO 8600-5:2020 | Conforms | Endoscope Image Quality | |
| IEC 62471:2006 | Conforms | Photobiological Safety | |
| ISO 8600-1:2015 | Conforms | Endoscope General Requirements | |
| ISO 8600-4:2014 | Conforms | Endoscope Test Methods | |
| ISO 12233:2017 | Conforms | Digital Image Still Camera Resolution | |
| ISO 15739:2017 | Conforms | Digital Still Camera Noise | |
| ISO/CIE 11664-4 | Conforms | Color Performance | |
| Wang, et al. (2016) | Conforms | Local Magnification Method for Geometric Distortion | |
| Wang et al. (2017) | Conforms | Field of View Measurement | |
| Wei-Chung Cheng (2023) | Conforms | Color Performance Analyzer | |
| Biocompatibility | FDA Guidance "Use of International Standard ISO 10993-1" | Conforms | Cytotoxicity, Sensitization, Irritation, Acute Systemic, Pyrogenicity |
| Sterility & Shelf-life | ISO 11135:2014 | Conforms | Ethylene Oxide Sterilization |
| ISO 11737-1:2018 | Conforms | Sterilization of Healthcare Products - Microbiological Methods - Part 1: Determination of a Population of Microorganisms on Products | |
| ISO 11737-2:2019 | Conforms | Sterilization of Healthcare Products - Microbiological Methods - Part 2: Tests on Sterility Assessed Through Microorganism Detection | |
| ISO 10993-7:2008 | Conforms | Ethylene Oxide Sterilization Residuals | |
| ASTM F1980-2016 | Conforms | Accelerated Aging | |
| ASTM F88/F88M-15 | Conforms | Seal Strength | |
| ASTM D4169-23e1 | Conforms | Performance Testing of Shipping Containers and Systems |
Discussion of Differences (from Comparison Table, if differences existed):
The document states for "Maximum insertion portion width(mm)" and "Field of view (degree)" that these are "Similar" or "Same" after analysis, concluding that "Only differences in specifications and dimensions. All the performance was tested and the results met the standard requirements, this difference will not raise any issues in safety and effectiveness." This indicates that any numerical differences in these parameters were evaluated against the relevant standards and found to be acceptable.
2. Sample size used for the test set and the data provenance
The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no "test set" in the context of clinical data. The testing performed was non-clinical bench testing to demonstrate compliance with recognized industry standards and evaluate engineering performance, biocompatibility, and sterilization effectiveness.
- Sample Size for Bench Testing: The document does not specify the exact number of units or samples used for each non-clinical test (e.g., how many ureteroscopes were tested for bending angle, how many samples for biocompatibility). This level of detail is typically found in the full test reports, not the 510(k) summary.
- Data Provenance: The data provenance is from non-clinical laboratory and bench testing, likely conducted by the manufacturer or accredited testing facilities. There is no mention of country of origin for this testing, but it can be inferred the testing supports a device manufactured by Dongguan ZSR Biomedical technology Company Limited in the PEOPLE'S REPUBLIC OF CHINA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no clinical study was conducted, there was no clinical "test set" requiring expert ground truth establishment. The "ground truth" for the non-clinical tests is defined by the objective metrics and thresholds established in the referenced international standards (e.g., ISO, IEC, ASTM).
4. Adjudication method for the test set
Not applicable. There was no clinical test set requiring an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical medical instrument (ureteroscope and imaging processor), not an AI/software device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not a standalone algorithm.
7. The type of ground truth used
The "ground truth" for this 510(k) submission is derived from:
- International Standards and Recognized Test Methods: For performance, biocompatibility, and sterility, the ground truth is compliance with the specifications and thresholds defined in the referenced standards (e.g., ISO, IEC, ASTM).
- Predicate Device Characteristics: For determining substantial equivalence, the technological characteristics and performance of the legally marketed predicate device (K230200) serve as a baseline for comparison.
8. The sample size for the training set
Not applicable. This device is a physical medical instrument, and no machine learning algorithm development (which would require a training set) is mentioned or implied.
9. How the ground truth for the training set was established
Not applicable. There was no training set.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.